Cephalon's Next Big Thing

A series of fast-moving events has once again put Cephalon (CEPH) in Wall Street's spotlight.

Between early December and early February, Cephalon negotiated a flurry of deals with generic drugmakers, protecting the patent for its sleep-disorders drug Provigil. The next big moment will come three weeks from now, when the experimental drug Sparlon goes before a panel of medical advisers to the Food and Drug Administration.

Cephalon's goal will be to distinguish Sparlon from the other drugs for attention deficit hyperactivity disorder that are now under heightened regulatory scrutiny.

Because Cephalon says Sparlon differs from other ADHD drugs, analysts say the company could get a boost if the FDA agrees and at the same time says other drugs need stronger warnings.

"We note that the vast majority of ADHD drugs are stimulants where there have traditionally been concerns about the potential for addiction and abuse, and Sparlon is a nonstimulant," says Gary Nachman of Leerink Swann in a recent research report. Nachman, who has an outperform rating, doesn't own shares. His firm has had a non-investment-banking relationship with Cephalon.

Another analyst, Bret Holley of CIBC World Markets, wrote in a Feb. 15 research report that the "recent concerns of cardiovascular toxicities of stimulant-class ADHD drugs could give Sparlon a marketing advantage in terms of risk/benefit. We are not aware of any major safety concerns specific to Sparlon." Holley, who doesn't own shares, has an overweight rating on Cephalon. His firm has had an investment-banking relationship.

The ADHD market was jolted on Feb. 9 when a panel of medical experts recommended that most drugs should carry a black box warning alerting patients and doctors about potential cardiovascular risks. A black box is the strongest FDA warning.

The FDA isn't bound by its advisory panels' recommendations, and the 8-7 vote, with one abstention, suggests there will be fierce debate within the agency regarding the black box labels. The advisory committee focused on drug safety and risk management.